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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Dose, Radionuclide
510(k) Number K943072
Device Name BETA C COUNTER
Applicant
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact MARY A DELL, M.S.
Correspondent
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact MARY A DELL, M.S.
Regulation Number892.1360
Classification Product Code
KPT  
Date Received06/28/1994
Decision Date 09/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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